Statistical Programmer II
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Job Description
R-focused Statistical Programmer II analytics for clinical trials at Parexel. Working remotely to contribute to high-visibility studies with a focus on regulatory compliance and data quality.
Responsibilities:
- Assist in coordinating project start-up activities, including global program creation, tracking spreadsheets, and required documentation.
- Continuously check your own work to ensure first-time quality.
- Apply efficient programming techniques to produce derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings of any complexity; perform QC for low–medium complexity datasets, tables, figures, and listings.
- Assist in producing and QC’ing derived dataset specifications, process-supporting documents, and submission documentation.
- Maintain and expand knowledge of both local and international regulatory requirements within clinical research.
- Build expertise in SAS and gain an understanding of processes within other Parexel functional areas.
- Provide relevant training and mentorship to colleagues and project teams.
- Maintain complete and accurate study documentation according to SOPs/Guidelines to ensure traceability and regulatory compliance.
- Ensure compliance with SOPs/Guidelines, ICH-GCP, and other applicable regulations (including 21 CFR Part 11); participate in internal/external audits and regulatory inspections as needed.
- Proactively contribute to process and quality improvement initiatives.
- Understand regulatory expectations related to industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions).
Requirements:
- Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences
- Excellent analytical skills
- Intermediate proficiency in the R programming language
- Knowledge of programming and reporting processes
- Understanding of SOPs/Guidelines, ICH-GCP, and applicable regulations such as 21 CFR Part 11
- Ability to learn new systems and work effectively in an evolving technical environment
- Strong ability to manage competing priorities and adapt to change
- Proven success working as part of a global team
- Effective time management to meet daily metrics and team objectives
- Business and operational skills including customer focus, commitment to quality, and problem-solving
- Strong understanding of CDISC standards
- Knowledge of statistical terminology, clinical tests, and protocol designs
- Excellent attention to detail with a commitment to quality
- Strong written and verbal English communication skills.
Benefits:
- Exceptional long-term career security
- Opportunities to work with leading global biopharma and biotech organizations
- An extensive pipeline of impactful clinical research projects
- A supportive environment that values work–life balance and professional growth
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